A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00501397
First received: July 13, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

The purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole causes GSK189075 to stay in your bloodstream for a longer period of time. It will also examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Drug: ketoconazole
Drug: GSK189075
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK189075

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3 [ Time Frame: at Day 1 Session 1, Days 5 & 6 Session 3 urine collections for volume ]
  • urine collections for volume, glucose, & creatinine at Day 1 Session 1, Days 5 & 6 Session 3. [ Time Frame: at Day 1 Session 1, Days 5 & 6 Session 3. ]

Secondary Outcome Measures:
  • Adverse events: all visits [ Time Frame: all visits ]
  • ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3 [ Time Frame: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3 ]
  • Labs:followup [ Time Frame: followup ]
  • Urine: Day 1 Session 1,Days 5-6 Session 3 [ Time Frame: Day 1 Session 1,Days 5-6 Session 3 ]
  • Vitals: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup [ Time Frame: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup ]

Enrollment: 22
Study Start Date: February 2007
Intervention Details:
    Drug: ketoconazole Drug: GSK189075
    Other Names:
    • GSK189075
    • ketoconazole
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are a healthy, non-smoking male or female.
  • Are 18 to 55 years old, inclusive.
  • Have a body weight of > or equal to 110 pounds.
  • Are a female who is unable to have any more children and have a negative pregnancy test.
  • Are willing and able to provide written informed consent before the start of any study-related procedures.
  • Are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.

Exclusion Criteria:

  • Smoke or use any tobacco products.
  • Have a known allergic reaction to ketoconazole or study drug.
  • Have a history of regular alcohol consumption greater than 7 drinks per week for females or greater than 14 drinks per week for males.
  • Have a positive drug or alcohol or smoking test at screening or check-in to the clinic.
  • Have participated in another clinical trial within 30 days prior to screening in which you have received an investigational drug.
  • Have donated a pint of blood within 56 days before the first dose of study drug.
  • Have any known or suspected stomach condition (or stomach surgery within the 6 months prior to dosing).
  • Have abnormal liver test results.
  • Have a documented history or diagnosis of cirrhosis.
  • Have positive results for hepatitis C or B, or HIV at screening.
  • Have blood pressure outside of the normal range.
  • Are a male subject who is unwilling to either abstain from sexual activity or unwilling to use birth control during the course of the study.
  • Are using non-prescription drugs, vitamins, herbal or dietary supplements (including St John's Wort) within 7 days before the first dose of study medication,
  • Have any abnormality identified on the screening physical or laboratory examination that the study physician feels would make it inappropriate for you to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501397

Locations
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00501397     History of Changes
Other Study ID Numbers: KG2108197
Study First Received: July 13, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
ketoconazole,
drug interaction,
pharmacokinetics
T2DM,

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ketoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014